36 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE
MaxFuse,VBR, 12 (D) x 14 (W) x 35 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056339·12 (D) x 14 (W) x 35 (H)
QUANTUM RING FIXATION SYSTEM MODEL ISF
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXI-LITE, MODEL FL-V1.2
FDA 510(k)
FDA Class 2
·Anesthesiology
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code HAW·November 10, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·April 11, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·March 15, 2018
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code HAW·June 15, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 10, 2017
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·March 21, 2018
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 16, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 9, 2017
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·January 26, 2018
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
INTRALASE LASER
FDA Adverse Event
Injury
·INTRALASE CORP·Product code GEX·June 3, 2013
STERLING?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·October 8, 2014
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code HAW·November 6, 2017